NCT03968302

ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION

ADDITION OF BISMUTH TO THE STANDARD TRIPLE THERAPY FOR HELICOBACTER PYLORI ERADICATION: A RANDOMIZED CONTROLLED STUDY

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Ziauddin University · Academic / Other
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Accepted

Summary

H pylori is an important cause of chronic gastritis and other complications. There is a decline in eradication rate for H pylori owing to multiple factors including drug resistance. We compare the effect of the addition of bismuth to the standard triple therapy in a randomized control trial. Subjects were randomized into two arms. Arm A received triple therapy including amoxicillin, clarithromycin, and omeprazole and Arm B received quadruple therapy adding colloidal bismuth subcitrate. Both arms received treatment for two weeks.

Detailed description

The study is a 2-arm, prospective, randomized, non-inferiority, unblinded, parallel design trial. The primary end point is post-treatment result after triple or quadruple therapy. Secondary endpoints included the nature and frequency of side effects compared between the two arms. The study protocol was approved by the ethical review committee of the university. Patients with dyspeptic symptoms who had H pylori infection, diagnosed through positive Stool for H pylori antigen or presence of H. pylori organism in the histopathology of gastric mucosal biopsy, attending outpatient department of two campuses of the University Hospital were included in this study.. Group A received standard triple therapy for H. pylori eradication for a total 14 days and group B received bismuth-based quadruple therapy for H pylori eradication for the same period. The triple regimen was defined as a combination of amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose. Quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily, in addition. H. Pylori status was checked routinely after 6 weeks by Stool sampling for H, pylori antigen. Subjects were counseled to stop taking PPI or any antibiotic 2 weeks before stool H. pylori antigen testing. Eradication of H pylori was defined as lack of detection of H pylori antigen in the stool via ELISA method after triple or quadruple therapy.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	ARM A Triple therapy for helicobacter pylori	The triple regimen was defined as a combination of amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose.
DRUG	ARM B Quadruple therapy for helicobacter pylori	Quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily,amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose.

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2019-05-30
• Last updated: 2019-05-30

Locations

1 site across 1 country: Pakistan